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FDA Reversal Gives Amicus Renewed Hope For US Oral Fabry Launch

 
• By Jessica Merrill

Amicus plans to file migalastat for Fabry disease in the US in the fourth quarter, after FDA gave the greenlight, reversing a decision last year to require an additional Phase III study.

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It's not often that FDA backtracks on a decision, but in a surprising turn of events, the agency has reversed a decision on Amicus Therapeutics Inc.'s oral therapy for Fabry disease, migalastat, agreeing the company can submit an NDA for accelerated review based on existing data.

The company announced July 11 that it now plans to file an NDA for migalastat in the fourth quarter, following a series of discussions and written communications with the agency, which could

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